BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202398 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04756
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTHCARE PROVIDER (HCP) THAT A PATIENT EXPERIENCED WITHDRAWAL. IT WAS STATED THAT THE PATIENT HAD 2 EPISODES OF DRUG WITHDRAWAL OVER THE PAST 3-4 WEEKS. THE PATIENT SYMPTOMS WERE REPORTED AS HYPERTENSION, "HORRIFIC PAIN", AND SOME "FLU-LIKE SYMPTOMS." ON (B)(6) 2012, THAT PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) WHERE THE CATHETER ACCESS PORT (CAP) WAS ASPIRATED AND THEN A THERAPEUTIC BOLUS WAS GIVEN AND THE PATIENT RESPONDED WELL TO IT. THE WERE NO PUMP ALARMS REPORTED. THERE WAS NO VOLUME DISCREPANCY NOTED AND NO DIAGNOSTIC STUDIES WERE PERFORMED. IT WAS FURTHER REPORTED THAT ON A DIFFERENT OCCASION, THE HCP TRIED TO PERFORM A DYE STUDY, HOWEVER, THE CAP COULD NOT BE ASPIRATED. THE HCP ULTIMATELY REPLACED THE PROXIMAL SEGMENT OF THE CATHETER AND SPLICED IT BACK TOGETHER (HOWEVER IT WAS REPORTED IN (B)(6) 2012 THAT THE REVISION IN (B)(6) 2012 REPLACED THE SPINAL SEGMENT. IT IS UNCLEAR WHAT PIECE WAS REVISED, HOWEVER IT WILL BE INTERPRETED THAT THE PROXIMAL END WAS REPLACED SINCE THAT WAS THE INFORMATION FIRST REPORTED.) THE DATE OF THE REVISION WAS UNKNOWN. IT WAS STATED THAT THE CATHETER WAS THEN "TOTALLY PATENT." ADDITIONAL INFORMATION RECEIVED IN JUNE 2012 REPORTED THAT THE HCP THOUGHT THE ISSUE WAS WITH THE CATHETER, DUE TO "THESE TWO THINGS." IT WAS NOTED THAT TWO MORE STALLS OCCURRED. THE HCP CONSIDERED REPLACING THE ENTIRE CATHETER THIS TIME. IT WAS LATER REPORTED IN (B)(6) 2013 THAT THE PATIENT HAD A "SPINAL SURGERY" IN (B)(6) 2012, HOWEVER IT WAS STATED THAT NOTHING WAS DONE TO THE PUMP OR THE CATHETER AT THAT TIME. NO KINKS OR FRACTURES WERE FOUND, BUT SINCE THE PATIENT REPORTED INCREASED PAIN, THE ENTIRE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER ((B)(6) 2012, PLEASE REFER TO MFG. REPORT # 3004209178-2012-04965 FOR THE EVENTS PERTAINING TO THIS EVENT). IT WAS UNCLEAR IF A CATHETER REVISION TOOK PLACE IN (B)(6) 2012, HOWEVER SINCE THE HCP PARTNER REPORTED REPLACING THE PROXIMAL PORTION OF THE CATHETER IT WAS BEING INTERPRETED AS A REVISION TAKING PLACE. MEDICATIONS IN THE PUMP: FENTANYL 1116.1MCG/DAY, CLONIDINE 348.8MCG/DAY, BUPIVACAINE 2.098MG/DAY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301022 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention